A Fifth Circuit panel reinstated mifepristone's in-person dispensing rule nationwide; Justice Alito issued successive emergency stays as the full Supreme Court deliberated.
A unanimous three-judge Fifth Circuit panel granted Louisiana's emergency motion on May 1, immediately reinstating the federal in-person dispensing requirement for mifepristone and cutting off telehealth and mail-order access to the drug nationwide [1][2]. The ruling reversed regulatory accommodations the Food and Drug Administration had extended under the drug's Risk Evaluation and Mitigation Strategy, or REMS, framework, which had permitted certified pharmacies and telehealth providers to dispense the medication without a patient's physical presence [3].
The case, *State of Louisiana v. FDA*, is pending before the U.S. Court of Appeals for the Fifth Circuit in New Orleans, where Louisiana sought emergency relief after a district court declined to block the FDA's telehealth-access provisions [2][3]. Manufacturers Danco Laboratories and GenBioPro, both approved makers of mifepristone, moved immediately to the Supreme Court after the Fifth Circuit's May 1 order took effect [1][2]. Justice Samuel Alito issued an administrative stay on May 4, halting enforcement of the Fifth Circuit's order while the full Court deliberated [2]. Alito extended that stay through May 11, then again through May 14 at 5:00 p.m. ET, with the full Court expected to resolve whether to grant a longer stay pending appeal by that deadline [1].
The litigation carries stakes that extend well beyond Louisiana. Mifepristone, used in combination with misoprostol, accounts for roughly 63% of all abortions performed in the United States [2]. If the Fifth Circuit's order is permitted to stand, patients in states where abortion remains legal would lose access to the drug through mail-order pharmacies and remote prescriptions, effectively narrowing a dominant method of pregnancy termination even absent a state-level prohibition [1][3]. The FDA is simultaneously conducting a comprehensive review of the drug's REMS, directed by the Department of Health and Human Services, a process that could independently alter the drug's dispensing conditions regardless of the litigation's outcome [3].
Practitioners watching the Supreme Court's shadow docket note that the successive administrative extensions, each measured in days, signal active deliberation among the justices rather than a pro forma hold [1][3]. The Court's ultimate disposition on the stay will determine whether the Fifth Circuit's nationwide in-person mandate remains suspended through the appeal. If the stay is denied or lapses, enforcement resumes immediately, and Danco and GenBioPro would need to seek further relief or proceed to expedited briefing on the merits before the Fifth Circuit [2][3].